Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort (NCT NCT02242305)
NCT ID: NCT02242305
Last Updated: 2017-07-27
Results Overview
The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from "no pain" to "the most severe pain imaginable").
COMPLETED
PHASE3
302 participants
3 days (1 day)
2017-07-27
Participant Flow
Participant milestones
| Measure |
Hyoscine Butylbromide - Tablet (Tab.)
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule (Cap.)
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
151
|
|
Overall Study
COMPLETED
|
145
|
141
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
Hyoscine Butylbromide - Tablet (Tab.)
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule (Cap.)
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Overall Study
Without spasm-like pain during 3 weeks
|
1
|
4
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Non-compliance dosing regimen or visit
|
2
|
2
|
|
Overall Study
Subject withdraws inform consent
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort
Baseline characteristics by cohort
| Measure |
Hyoscine Butylbromide - Tablet
n=146 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=142 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 Years
STANDARD_DEVIATION 12.49 • n=5 Participants
|
41.9 Years
STANDARD_DEVIATION 12.05 • n=7 Participants
|
42.6 Years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 days (1 day)Population: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.
The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from "no pain" to "the most severe pain imaginable").
Outcome measures
| Measure |
Hyoscine Butylbromide - Tablet
n=141 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=140 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
Within 3 days
|
-2.48 Units on a scale
1.968
|
-2.45 Units on a scale
1.879
|
|
Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
Within 1 day
|
-2.36 Units on a scale
1.984
|
-2.31 Units on a scale
1.914
|
SECONDARY outcome
Timeframe: Up to 3 days.Population: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.
The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: "How many times have the spasm-like pains occurred today?" 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.
Outcome measures
| Measure |
Hyoscine Butylbromide - Tablet
n=141 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=140 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
Day 1-Baseline
|
-0.4 Units on a scale
Standard Deviation 0.77
|
-0.2 Units on a scale
Standard Deviation 0.73
|
|
Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
Day 3-Baseline
|
-1.0 Units on a scale
Standard Deviation 0.94
|
-0.8 Units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Post 3 days of treatment.Population: Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.
The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).
Outcome measures
| Measure |
Hyoscine Butylbromide - Tablet
n=143 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=141 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Global Assessment of Efficacy by Patient on 4-point Scale
Good
|
35 Participants
|
35 Participants
|
|
Global Assessment of Efficacy by Patient on 4-point Scale
Satisfactory
|
69 Participants
|
76 Participants
|
|
Global Assessment of Efficacy by Patient on 4-point Scale
Not satisfactory
|
37 Participants
|
30 Participants
|
|
Global Assessment of Efficacy by Patient on 4-point Scale
Bad
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 days.Population: Safety Set (SFS): All randomized subjects who took at least one dose of study medication.
The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.
Outcome measures
| Measure |
Hyoscine Butylbromide - Tablet
n=146 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=142 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Number of Patients With Adverse Events
Subjects with AE: Severe
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Subjects with AE
|
10 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events
Subjects with treatment related AE
|
5 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events
Subjects with Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
AE leading to discontinuation from treatment
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events
Subjects with AE: Mild
|
10 Participants
|
10 Participants
|
|
Number of Patients With Adverse Events
Subjects with AE: Moderate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 3.Population: Safety Set (SFS): All randomized subjects who took at least one dose of study medication.
The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).
Outcome measures
| Measure |
Hyoscine Butylbromide - Tablet
n=145 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=141 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Global Assessment of Tolerability by Investigator on a 4-point Scale
Good
|
51 Participants
|
47 Participants
|
|
Global Assessment of Tolerability by Investigator on a 4-point Scale
Satisfactory
|
72 Participants
|
72 Participants
|
|
Global Assessment of Tolerability by Investigator on a 4-point Scale
Not satisfactory
|
21 Participants
|
22 Participants
|
|
Global Assessment of Tolerability by Investigator on a 4-point Scale
Bad
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 days.Population: Safety Set (SFS): All randomized subjects who took at least one dose of study medication.
Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).
Outcome measures
| Measure |
Hyoscine Butylbromide - Tablet
n=146 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=142 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
Urinary White Bllood Cell count abnormalities
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
Urinary Red Blood Cell count abnormalities
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
Urinary albumin abnormalities
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
White Blood Cell count abnormalities
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
Platelet count abnormalities
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.Population: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.
This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.
Outcome measures
| Measure |
Hyoscine Butylbromide - Tablet
n=141 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.
|
Hyoscine Butylbromide - Capsule
n=140 Participants
The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.
|
|---|---|---|
|
Percentage of Event for Time to Therapeutic Effect
|
93.6 Percentage of event
|
92.1 Percentage of event
|
Adverse Events
Hyoscine Butylbromide - Tablet
Hyoscine Butylbromide - Capsule
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER